# Patent

## Title
Lock bar spring and clip for implant deployment device

## Abstract

A system for closing an aperture in a biological tissue includes an implant deployment device having at least one frame arm. At least one clip is connected to the at least one frame arm and configured to releasably retain a surgical implant to the frame arm. A lock bar including at least one spring member is disposed on the at least one frame arm and is configured to bias the clips towards a closed position.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
The present application is a continuation-in-part of U.S. patent application Ser. No. 13/451,962, filed on Apr. 20, 2012, now U.S. Pat. No. 8,753,361, which is a continuation-in-part of U.S. patent application Ser. No. 12/891,962, filed on Sep. 28, 2010, now U.S. Pat. No. 8,758,373, which is a continuation-in-part of U.S. patent application Ser. No. 12/834,456, filed Jul. 12, 2010, now U.S. Pat. No. 8,753,359, which is a continuation-in-part of PCT international patent application number PCT/IL2009/000188, filed Feb. 18, 2009, which claims the benefit of and priority to U.S. provisional patent application Ser. No. 61/029,386, filed Feb. 18, 2008. The present application also claims the benefit of and priority to U.S. provisional patent application Ser. No. 61/691,859, filed Aug. 22, 2012, which claims the benefit of and priority to U.S. provisional patent application Ser. No. 61/691,860, filed Aug. 22, 2012, which claims the benefit of and priority to U.S. provisional patent application Ser. No. 61/691,863, filed Aug. 22, 2012, which claims the benefit of and priority to U.S. provisional patent application Ser. No. 61/691,864, filed Aug. 22, 2012, which claims the benefit of and priority to U.S. provisional patent application Ser. No. 61/691,866, filed Aug. 22, 2012, which claims the benefit of and priority to U.S. provisional patent application Ser. No. 61/691,869, filed Aug. 22, 2012. The present application also claims the benefit of and priority to U.S. provisional patent application Ser. No. 61/302,186, filed Feb. 8, 2010. The contents of each of these prior applications are incorporated by reference herein in their entirety.


FIELD OF THE INVENTION
This invention generally relates to a device and method for reversibly coupling an implant to an implant deployment device.
BACKGROUND
An object of the present invention is to provide an apparatus and a method for performing corrective surgery on internal wounds such as a hernia where invasion of the patient's body tissues is minimized and resultant trauma is reduced.
A hernia is a protrusion of a tissue, structure, or part of an organ through the muscular tissue or the membrane by which it is normally contained. In other words, a hernia is a defect in the abdominal wall through which a portion of the intra-abdominal contents can protrude. This often causes discomfort and an unsightly, visible bulge in the abdomen. When such a hernia defect occurs in the abdominal region, conventional corrective surgery has required opening the abdominal cavity by surgical incision through the major abdominal muscles. While this technique provides for effective corrective surgery of the hernia defect, it has the disadvantage of requiring a hospital stay of as much as a week, during which pain is frequently intense, and it requires an extended period of recuperation. After the conventional surgery, patients frequently cannot return to a full range of activity and work schedule for a month or more. Accordingly, medical science has sought alternative techniques that are less traumatic to the patient and provide for more rapid recovery.
Laparoscopy is the science of introducing a viewing instrument through a port into a patient's body, typically the abdominal cavity, to view its contents. This technique has been used for diagnostic purposes for more than 75 years. Operative laparoscopy is performed through tiny openings in the abdominal wall called ports. In most surgical techniques, several ports, frequently three to six, are used. Through one port is inserted the viewing device, which conventionally comprises a fiber optic rod or bundle having a video camera affixed to the outer end to receive and display images from inside the body. The various surgical instruments are inserted through other ports to do the surgery that normally would be performed through an open incision through the abdominal wall. Because the laparoscopic surgical techniques require only very small holes through the abdominal wall or other portions of the body, a patient undergoing such surgery may frequently leave the hospital within one day after the surgery and resume a full range of normal activities within a few days thereafter.
In repairing hernia the physician needs to first deploy the implant and then attach the implant to the tissue.
There are many patents and patent applications relating to attaching a prosthesis implant to a tissue via tacks. Each patent and patent application describes a different attachment mechanism via different anchoring means (see for example U.S. Pat. No. 6,447,524). Traditional anchors used in surgery include clips, staples, or sutures, and may also be referred to as tissue anchors. These devices are usually made of a biocompatible material (or are coated with a biocompatible material), so that they can be safely implanted into the body.
Most tissue anchors secure the tissue by impaling it with one or more posts or legs that are bent or crimped to lock the tissue into position. Thus, most traditional anchors are rigid or are inflexibly attached to the tissue. For example PCT No. WO 07/021834 describes an anchor having two curved legs that cross in a single turning direction to form a loop. Those two curved legs are adapted to penetrate tissue in a curved pathway. U.S. Pat. No. 4,485,816 describes surgical staple made of shape memory alloy. The staple is placed in contact of the tissue and then heated. The heating causes the staple to change its shape thus, penetrating the tissue.
U.S. Pat. No. 6,893,452 describes a tissue attachment device that facilitates wound healing by holding soft tissue together under improved distribution of tension and with minimal disruption of the wound interface and its nutrient supplies.
U.S. Pat. No. 6,517,584 describes a hernia implant which includes at least one anchoring device made of shape memory material. The anchoring devices are initially secured to the prosthesis by being interlaced through a web mesh constituting the prosthesis. The attachment is obtained by altering the attachment element's shape from rectilinear to a loop shape due to heat induced shape memory effect.
Yet other patent literature relates to devices for endoscopic application of surgical staples adapted to attach surgical mesh to a body tissue.
An example of such a teaching is to be found in U.S. Pat. No. 5,364,004; U.S. Pat. No. 5,662,662; U.S. Pat. No. 5,634,584; U.S. Pat. No. 5,560,224; U.S. Pat. No. 5,588,581; and in U.S. Pat. No. 5,626,587.
There are a few patent and patent applications teaching the deployment of implants. For example U.S. Pat. No. 5,836,961 which relates to an apparatus used for developing an anatomic space for laparoscopic hernia repair and an implant for use therewith. The apparatus of U.S. Pat. No. 5,836,961 comprises a tubular introducer member having a bore extending therethrough. A tunneling shaft is slidably mounted in the bore and has proximal and distal extremities including a bullet-shaped tip. A rounded tunneling member is mounted on the distal extremity of the tunneling shaft. The apparatus comprises an inflatable balloon. Means is provided on the balloon for removably securing the balloon to the tunneling shaft. Means is also provided for forming a balloon inflation lumen for inflating the balloon. The balloon is wrapped on the tunneling shaft. A sleeve substantially encloses the balloon and is carried by the tunneling shaft. The sleeve is provided with a weakened region extending longitudinally thereof, permitting the sleeve to be removed whereby the balloon can be unwrapped and inflated so that it lies generally in a plane. The balloon as it is being inflated creates forces generally perpendicular to the plane of the balloon to cause pulling apart of the tissue along a natural plane to provide the anatomic space.
More patent literature can be found in PCT No. WO 08/065653 which relates to a device especially adapted to deploy an implant within a body cavity. The device is an elongate open-bored applicator and comprises (a) at least one inflatable contour-balloon, (b) at least one inflatable dissection balloon. The inflatable contour-balloon and the inflatable dissection balloon are adjustable and located at the distal portion. The elongate open-bored applicator additionally comprises (c) at least one actuating means located at the proximal portion. The actuating means is in engagement with the inflatable contour-balloon and the inflatable dissection balloon. The actuating means is adapted to provide the inflatable contour-balloon and the inflatable dissection balloon with independent activation and/or de-activation.
Although all the above described patents and patent applications demonstrate attachment means or deployment means, none of the literature found relates to a reversible connection device which enable a reversible coupling between the implant and the implant deployment device.
Thus, there is still a long felt need for a device that will enable a reversible connection between the implant and the implant deployment device.
SUMMARY
It is one object of the present invention to provide an active reversible connection mechanism adapted to provide a reversible attachment between a prosthetic implant and an implant deployment device, wherein said attachment can be actively reversed without requiring any application of force on said implant.
It is another object of the present invention to provide the active reversible connection mechanism as defined above, wherein said active reversible connection mechanism comprising at least one clip, hinge-like coupled to said implant deployment device, adapted to attach said implant to said implant deployment device: Said clip is characterized by having at least three configurations: (i) a horizontal configuration in which said clip is substantially horizontal with respect to said implant deployment device; (ii) a vertical configuration in which said clip is substantially vertical with respect to said implant deployment device; and, (iii) a free motion configuration in which said clip is free to rotate; such that (i) when said clip is in said horizontal configuration said attachment between said implant and said implant deployment device is obtained; (ii) when said clip is in said free motion configuration said detachment between said implant and said implant deployment device is obtained.
It is another object of the present invention to provide the active reversible connection mechanism as defined above, additionally comprising at least one locking bar characterized by at least two configurations: (i) lock configuration in which said lock bar maintains said clip in said horizontal configuration; and, (ii) free configuration in which said locking bar enables said clip a free movement.
It is another object of the present invention to provide the active reversible connection mechanism as defined above, wherein said active reversible connection additionally comprising at least one detachment actuator adapted to reversibly transform said locking bar from said lock configuration to said free configuration.
It is another object of the present invention to provide the active reversible connection mechanism as defined above, wherein said attachment between said implant and said implant deployment device is obtained once said locking bar is in its said lock configuration and said at least one clip is in said horizontal configuration such that the same at least partially penetrates said implant.
It is another object of the present invention to provide the active reversible connection mechanism as defined above, wherein said detachment is achieved by transforming said locking bar from said lock configuration to said free configuration via said at least one detachment actuator.
It is another object of the present invention to provide the active reversible connection mechanism as defined above, wherein said detachment actuator comprises a wire; further wherein said wire is attached to said lock bar.
It is another object of the present invention to provide the active reversible connection mechanism as defined above, wherein said transformation of said clip from said vertical configuration into their said horizontal configuration is performed manually by the physician or by the aid of a dedicated device.
It is another object of the present invention to provide a method for attaching a prosthetic implant to an implant deployment device. The method comprising steps selected, inter alia, from:

    
    
        a. obtaining an active reversible connection mechanism adapted to provide a reversible attachment between said prosthetic implant and said implant deployment device; wherein said attachment can be actively reversed without requiring any application of force on said implant; said active reversible connection comprising
        i. at least one clip, hinge-like coupled to said implant deployment device, adapted to attach said implant to said implant deployment device: Said clip is characterized by having at least three configurations: (i) horizontal configuration in which said clip is substantially horizontal with respect to said implant deployment device; (ii) a vertical configuration in which said clip is substantially vertical with respect to said implant deployment device; and, (iii) a free motion configuration in which said clip is free to rotate;
        ii. at least one locking bar characterized by at least two configurations: (i) lock configuration in which said lock bar maintains said clip in said horizontal configuration; and, (ii) free configuration in which said locking bar enables said clip a free movement; and,
        b. providing said clips in said vertical configuration;
        c. providing said locking bar in said lock configuration;
        d. threading said implant through said clip;
        e. transforming said clip into its said horizontal configuration thereby providing said attachment between said implant and said implant deployment device;
    
    


It is another object of the present invention to provide the method as defined above, additionally comprising the step of providing said active reversible connection with at least one detachment actuator.
It is another object of the present invention to provide the method as defined above, additionally comprising the step of reversibly transforming said locking bar from said lock configuration to said free configuration via said detachment actuator; thereby enabling free rotation of said clip such that detachment between said implant and said implant deployment device is obtained.
It is another object of the present invention to provide the method as defined above, additionally comprising the step of introducing said implant deployment device into a body cavity.
It is another object of the present invention to provide the method as defined above, additionally comprising the step of detaching said implant from said implant deployment device.
It is another object of the present invention to provide the method as defined above, wherein said detachment additionally comprising the steps of reversibly transforming said locking bar from said lock configuration to said free configuration via said detachment actuator; thereby enabling said clip to rotate freely such that said detachment between said implant and said implant deployment device is obtained.
It is another object of the present invention to provide a hernia kit useful in minimal invasive hernia surgery, comprising:

    
    
        a. an implant;
        b. an implant deployment device, adapted to deploy said implant within the abdominal cavity; and,
        c. an active reversible connection mechanism for reversible attaching said implant to said implant deployment device;
        wherein attachment can be actively reversed without requiring any application of force on said implant.
    
    


It is another object of the present invention to provide the hernia kit as defined above, wherein said active reversible connection mechanism comprising:

    
    
        a. at least one clip, hinge-like coupled to said implant deployment device, adapted to attach said implant to said implant deployment device: Said clip is characterized by having at least three configurations: (i) horizontal configuration in which said clip is substantially horizontal with respect to said implant deployment device; (ii) a vertical configuration in which said clip is substantially vertical with respect to said implant deployment device; and, (iii) a free motion configuration in which said clip is free to rotate; such that (i) when said clip is in said horizontal configuration said attachment between said implant and said implant deployment device is obtained; (ii) when said clip is in said free motion configuration said detachment between said implant and said implant deployment device is obtained.
    
    


It is another object of the present invention to provide the hernia kit as defined above, additionally comprising at least one locking bar characterized by at least two configurations: (i) lock configuration in which said lock bar maintains said clip in said horizontal configuration; and, (ii) free configuration in which said locking bar enables said clip a free movement.
It is another object of the present invention to provide the hernia kit as defined above, wherein said active reversible connection additionally comprising at least one detachment actuator adapted to reversibly transform said locking bar from said lock configuration to said free configuration.
It is another object of the present invention to provide the hernia kit as defined above, wherein said attachment between said implant and said implant deployment device is obtained once said locking bar is in its said lock configuration and said at least one clip is in said horizontal configuration such that the same at least partially penetrates said implant.
It is another object of the present invention to provide the hernia kit as defined above, wherein said detachment is achieved by transforming said locking bar from said lock configuration to said free configuration via said at least one detachment actuator.
It is still an object of the present invention to provide the hernia kit as defined above, wherein said detachment actuator comprises a wire; further wherein said wire is attached to said lock bar.
It is an object of the present invention to provide the hernia kit as defined above, wherein said transformation of said clip from said vertical configuration into their said horizontal configuration is performed manually by the physician or by the aid of a dedicated device.
At least one aspect of this disclosure includes a system for closing an aperture in a biological tissue, the system including a proximal portion adapted to remain outside the body, a distal portion adapted to be inserted into the body, the distal portion including at least one frame arm, at least one clip connected to the at least one frame arm and configured to releasably retain a surgical implant to the frame arm, and a lock bar including a body portion and at least one spring member disposed thereon configured to bias the at least one clip towards a closed position.
In at least one aspect of this disclosure, the at least one clip further comprises an extending portion forming a notch, wherein the extending portion includes at least one prong.
In at least one aspect of this disclosure, the at least one spring member further comprises a base portion disposed on or formed from the lock bar, a flex member attached to the base portion and configured to elastically flex and provide a restoring force, and a head disposed on the flex member configured to engage the at least one clip and apply the restoring force to the clip.
In at least one aspect of this disclosure, each clip further includes a bottom surface wherein the head engages the bottom surface of the at least one clip in at least one position.
In at least one aspect of this disclosure, the bottom surface is substantially flat.
In at least one aspect of this disclosure, the system further includes an extending portion forming a notch, wherein the extending portion includes at least one prong, wherein the head releasably contacts the notch to hold the at least one clip in an open position.
In at least one aspect of this disclosure, the head and notch are cammed to allow the head to slide out of engagement with the notch over the at least one prong as the at least one clip is torqued with a desired force to release the clip from the open position.
In at least one aspect of this disclosure, the head engages the bottom surface of the at least one clip when the head is disengaged or separated from the notch.
In at least one aspect of this disclosure, each clip further includes a hook, wherein when the clip is in an open position such that the hooks are not in contact with the frame arm, the bottom surface of the at least one clip forces the head downward and bends the flex member so that the flex member provides a restoring force through the head to the clip to bias the clip toward the closed position.
In at least one aspect of this disclosure, the lock bar further includes at least one stop member that slidably engages the bottom surface of the at least one clip when the lock bar is moved from an unlocked position to a locked position.
In at least one aspect of this disclosure, a system for closing an aperture in a biological tissue includes a proximal portion adapted to remain outside the body, a distal portion adapted to be inserted into the body, the distal portion including at least one frame arm, at least one clip connected to the at least one frame arm and configured to releasably retain a surgical implant to the frame arm, wherein each clip includes a hook, a body portion, a hinge hole, wherein each clip further includes a flat bottom surface, an extending portion forming a notch, wherein the extending portion includes at least one prong, and a lock bar including a body portion and at least one spring member disposed thereon configured to bias the at least one clip towards a closed position, wherein the at least one spring member further comprises a base portion disposed on or formed from the lock bar, a flex member attached to the base portion and configured to elastically flex and provide a restoring force, and a head disposed on the flex member configured to engage the at least one clip and apply the restoring force to the clip, wherein the head engages the bottom surface of the at least one clip in at least one position, wherein the head releasably contacts the notch to hold the at least one clip in an open position, wherein the head and notch are cammed to allow the head to slide out of engagement with the notch over the at least one prong as the at least one clip is torqued with a desired force to release the clip from the open position, wherein the head engages the bottom surface of the at least one clip when the head is out of engagement with the notch, wherein when the clip is in an open position such that the hooks are not engaging with the frame arm, the bottom surface of the at least one clip forces the head downward and bends the flex member so that the flex member provides a restoring force through the head to the clip to bias the clip toward the closed position.
In at least one aspect of this disclosure, a method includes the steps of providing a system for closing an aperture in a biological tissue, the system including, a proximal portion adapted to remain outside the body, a distal portion adapted to be inserted into the body, the distal portion including at least one frame arm, at least one clip connected to the at least one frame arm and configured to releasably retain a surgical implant to the frame arm, and a lock bar including a body portion and at least one spring member disposed thereon configured to bias the at least one clip towards a closed position, attaching a surgical implant to at least one clip, and allowing the at least one clip to rotate to the closed position under the bias of the at least one spring member.
In at least one aspect of this disclosure, the at least one clip further comprises an extending portion forming a notch, wherein the extending portion includes at least one prong.
In at least one aspect of this disclosure, the at least one spring member further comprises a base portion disposed on or formed from the lock bar, a flex member attached to the base portion and configured to elastically flex and provide a restoring force, and a head disposed on the flex member configured to engage the at least one clip and apply the restoring force to the clip.
In at least one aspect of this disclosure, each clip further includes a bottom surface, wherein the head engages the bottom surface of the at least one clip in at least one position.
In at least one aspect of this disclosure, the bottom surface is substantially flat.
In at least one aspect of this disclosure, the system further includes an extending portion forming a notch, wherein the extending portion includes at least one prong, wherein the head releasably engages the notch to hold the at least one clip in an open position.
In at least one aspect of this disclosure, the head and notch are cammed to allow the head to slide out of engagement with the notch over the at least one prong as the at least one clip is torqued with a desired force to release the clip from the open position.
In at least one aspect of this disclosure, the head contacts the bottom surface of the at least one clip when the head is out of engagement with the notch.
In at least one aspect of this disclosure, each clip includes a hook, wherein when the clip is in an open position such that the hooks are not in contact with the frame arm, the bottom surface of the at least one clip forces the head downward and bends the flex member so that the flex member provides a restoring force through the head to the clip to bias the clip toward the closed position.
In at least one aspect of this disclosure, the lock bar further includes at least one stop member that slidably contacts the bottom surface of the at least one clip when the lock bar is moved from an unlocked position to a locked position.



BRIEF DESCRIPTION OF THE DRAWINGS
The invention is herein described, by way of example only, with reference to the accompanying drawings, wherein:
FIG. 1A illustrates an example of an implant deployment device which comprises said active reversible connection mechanism;
FIGS. 2A-2D illustrate the internal operation of said active reversible connection mechanism;
FIGS. 3A-3E illustrate a method of using said active reversible connection mechanism for providing said reversible connection between said implant and said implant deployment device;
FIGS. 4A-4H illustrate an embodiment of a stapling apparatus adapted for providing a reversible connection by the active reversible connection mechanism;
FIG. 5 illustrates an embodiment of a staple return spring;
FIG. 6 illustrates an embodiment of a clip in accordance with the present disclosure;
FIG. 7 illustrates an embodiment of a lock bar having a spring member in accordance with the present disclosure;
FIGS. 8A-8C illustrate an embodiment of a clip and spring lock bar system in accordance with the present disclosure;
FIG. 9 illustrates another embodiment of a lock bar having a spring member in accordance with the present disclosure, with a plurality of clips moving from an open position to a closed position;
FIGS. 10A-10C illustrate an embodiment of a clip and spring lock bar system in accordance with the present disclosure, with a plurality of clips moving from an open position to a closed position;
FIG. 11 illustrates another embodiment of a lock bar having a spring member in accordance with the present disclosure; and
FIGS. 12A and 12B illustrate an embodiment of a clip and spring lock bar system in accordance with the present disclosure.



DETAIL DESCRIPTION OF THE SPECIFIC EMBODIMENTS
The following description is provided, alongside all chapters of the present invention, so as to enable any person skilled in the art to make use of the invention and sets forth the best modes contemplated by the inventor of carrying out this invention. Various modifications of the present disclosure should be apparent to those skilled in the art, since the generic principles of the present invention have been defined specifically to provide means and method for creating a reversible and active connection between an implant and an implant deployment device.
The present invention provides an active reversible connection mechanism between a prosthetic implant and an implant deployment device wherein said connection can be performed during a surgery at a standard surgery room by the medical staff.
Furthermore, the present invention provides means so as to enable the surgeon to actively eliminate said attachment once detachment between said implant deployment device and said implant is necessary.
It should be emphasized that some of the major advantages of the present invention, with respect to the prior art, is to provide a fast and intuitive method for creating a reliable connection between an implant and an implant deployment device in the surgery room. Embodiments of an implant include, but are not limited to, a surgical patch, a surgical mesh, or other biocompatible implants usable in repairing a defect in body tissue.
In addition, the present invention provides means to actively disconnect said implant from said implant deployment device, when said disconnection is desired without the need to exert large forces on said implant and/or said tissue.
The term “Hernia” refers hereinafter for umbilical hernia, hiatal hernia, ventral hernia, postoperative hernia, epigastric hernia, spiegelian hernia, inguinal hernia and femoral hernia, generally any abdominal wall related hernia.
The term “hinge” or “hinge-like connection” refers hereinafter as to a type of bearing that connects two solid objects, typically allowing only a limited angle of rotation between them. Two objects connected by an ideal hinge rotate relative to each other about a fixed axis of rotation (the geometrical axis of the hinge). Hinges may be made of flexible material or of moving components.
The term “hinge like connection” can refer to a standard hinge or to a living hinge (i.e., a thin flexible hinge (flexure bearing) made from plastic that joins two rigid parts together while allowing them to bend along the line of the hinge).
The term “controlled deployment” refers hereinafter to an implant deployment which is continuous. Thus, deployment using the presently disclosed implant deployment device is variable amongst a number of deployment levels between a fully opened position and a fully closed position rather than a binary arrangement that does not include any intermediate positions or levels between fully opened and fully closed. This is in contrast to some conventional deployment systems in which the deployment of the implant relies upon the elasticity of a loop member surrounding the implant such that the implant can be either fully folded or fully unfolded. No intermediate stages are enabled. In the present invention, there can be several deployment stages.
The term “bidirectional” or “fully reversible deployment” refers hereinafter to the deployment of the implant, which according to the present invention, is fully reversible. In other words, the implant deployment is bidirectional, i.e., the implant can be fully folded (i.e., deployed within the body) and then, if the surgeon desires, the implant can be fully unfolded simply by the reconfiguration of the flexible arms from the initial stage to the final stage and vice versa.
The term “minimally invasive surgery” refers hereinafter to procedures that avoid open invasive surgery in favor of closed or local surgery with fewer traumas. Furthermore, the term refers to a procedure that is carried out by entering the body through the skin or through a body cavity or anatomical opening, but with the smallest damage possible.
The term “articulation” refers hereinafter to a joint or juncture between two segments of the device. The articulating means of the present invention provides the ability to better adjust the device to the curvature of the treated tissue.
The term “orientation” refers hereinafter to the rotation of the mesh within the abdominal cavity so as to fit to the hernia. Usually the mesh is not symmetric in shape (e.g., rectangular or elliptical)—therefore it has different directions. By rotating the mesh within the abdominal cavity—one can decide which direction is turned where.
The term “adjusting” refers hereinafter to rolling, folding, and winding of the implant, thus preparing and enabling the insertion of said implant into the abdominal cavity.
The term “active reversible connection” refers hereinafter to a coupling between the implant and the implant deployment device implant deployment device in which the coupling/decoupling between the implant and the implant deployment device is enabled by an act performed by the user (namely the physician). Once said user performed said act, said coupling/decoupling is canceled.
According to the present invention the coupling/decoupling is obtained actively via the aid of dedicated clips which are characterized by at least two configurations:

    
    
        (a) substantially horizontal/parallel configuration (in which an attachment between the implant and the implant deployment device is provided);
        (b) substantially vertical configuration; and,
        (c) a configuration in which the clips are free to rotate.
    
    


Before explaining the figures, it should be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention can be carried out in various ways.
Reference is now being made to FIG. 1A illustrates an example of an implant deployment device 100 which comprises said active reversible connection mechanism.
Implant deployment device 100 is defined hereinafter as a surgical device which can introduce an implant into a body cavity of a patient; implant deployment device 100 can deploy said implant such that it is at least partially spared inside the body cavity; alternatively implant deployment device 100 can only introduce said implant into the body cavity without performing any deployment.
In general, implant deployment device 100 comprises at least two portions: a distal portion 101 and a proximal portion 102. The proximal portion is adapted to remain outside the body, adjacently to the user and the distal portion 101 is adapted to be inserted into the body.
The distal portion comprises at least one frame arm 104 to which the implant is attached. Each frame arm 104 comprises said active reversible connection mechanism which provides reversible attachment between each frame arm 104 and the implant 106 such that said implant can be rolled/folded on said distal portion 101, and inserted into the patient's body cavity through a laparoscopic cannula or a small incision.
It should be noted that the term reversible refers hereinafter to the ability to both attach the implant to the implant deployment device and to decouple the same from the implant deployment device.
Said active reversible connection mechanism comprises at least one clip 107. Said clip is coupled to said frame arm 104 by hinge tab 132. Said active reversible connection is covered by cover 131 which is attached to the frame arm 104. Cover 131 comprises at least one hinge tab 132 which is adapted to hold said clip 107 attached to frame arm 104 an to serve as a hinge allowing free rotation of said clip 107. Said hinge tab 132 is inserted through hinge hole 133, located at clip 107 and through hole 134, located at frame arm 104.
Reference is now being made to FIGS. 2A-2D which illustrate the internal operation of said active reversible connection mechanism. For the purpose of illustration only, cover 131 is removed from these drawings.
A locking bar 203 is located inside groove 204 at frame arm 104. Said locking bar 203 can move linearly inside said groove 204 and comprises at least one groove 205. Said locking bar 203 is characterized by at least two positions: free position, in which each of said groove/s 205 is substantially located below said clip 107 (see FIGS. 2C and 2D), and lock position, in which said groove 205 is located away from said clip 107 (see FIGS. 2A and 2B).
In the lock position of the locking bar 203, the clip 107 are substantially perpendicular to the frame arm 104; and in free position of the locking bar 203, the clip 107 are free to rotate (hence, as will be discussed hereinafter a detachment is enabled).
A disconnection wire 206 is attached to said locking bar 203. Said wire 206 can be pulled proximally to the proximal portion 102 and is adapted to transform said locking bar 203 from its said lock position into its said free position.
According to this embodiment, each clip 107 comprises at least 3 sections: protruding portion (PP) 201 adapted to protrude through said implant during said connection process, hinge hole 133, and locking tab 202 which is tilted toward frame arm 104.
Each of said clip 107 is characterized by at least two configurations: horizontal/parallel configuration in which said clip 107 is substantially horizontal and parallel to said frame arm 104 (FIGS. 2B, 2C) and vertical configuration in which said clip 107 is substantially vertical with respect to said frame arm 104 (FIGS. 2A and 2D).
At least one holding hole 207 is located at said locking bar 203 and is adapted to hold said clip 107 in its vertical configuration.
At least one niche 208 in located at frame arm 104 adapted to accommodate said locking tab 202 of said clip 107 while the clip 107 is in its said horizontal/parallel configuration.
Reference is now being made to FIGS. 3A-3D illustrating a method of using said active reversible connection mechanism in order to provide said reversible connection between said implant and said implant deployment device 100. Again, for the purpose of illustration only, cover 131 was removed from these drawings.
FIG. 3A illustrates the initial state of said active reversible connection mechanism in which all of said clip 107 are in their vertical configuration and said locking bar 203 is positioned in said lock position.
As can be seen in the figure, said locking tab 202 of each said clip 107 is located inside said holding hole 207, therefore each clip 107 is held in its said vertical configuration and can penetrate an implant 210 whilst the last is mounted on top of said implant deployment device (see FIG. 3B).
Once said implant is mounted, each of said clip 107 is transformed from said vertical configuration into their said horizontal configuration (see FIG. 3C).
Said transformation can be achieved either manually (i.e., the physician will manually rotate the clips 107 thereby transforming them from said vertical configuration into their said horizontal configuration) or by the aid of a dedicated device.
Once said clip 107 is transformed to its horizontal configuration while said locking bar is in its said lock position, said locking tab 202 is urged into niche 208. Since the locking tab 202 is titled inwardly, if said clip 107 is pulled upwardly in this state, the locking tab 202 is stopped by the upper edge of said locking bar 203, therefore, the rotation back to said vertical configuration of said clip 107 is limited by said locking bar 203 and said clips 107 are locked in said horizontal configuration, holding said implant attached to said frame arm 104.
It should be pointed out that it is a unidirectional mechanism. In other words, if one tries to force clips 107 to its vertical configuration, locking tabs 202 will ‘bump into locking bar 203.
By further pulling said locking bar 203 towards the proximal portion the clips 107 are unlocked and can be rotated be back to its vertical configuration (see FIGS. 3D and 3E).
Once detachment between said implant 210 and said implant deployment device in desired, locking bar 203 is pulled backward by wire 206, changing the position of said locking bar form its said lock position into its said free position (see FIG. 3D). In said free position of the locking bar 203, the clips 107 are free to rotate (hence, as will be discussed hereinafter, a detachment between the implant deployment device and the implant is enabled).
Once locking bar 203 is positioned in said free position, said groove's 205 is located below said clips 107, therefore said locking bar 202 is no longer limiting the movement of said clips 107 enabling their free movement. In this state, detachment can be obtained by simply pulling said frame arm 104 away from said implant; as a result, said clips 107 rotate back into their said vertical configuration and are released from said implant (see FIG. 2E).
Reference is now made to FIG. 4A-4H, which illustrate an embodiment of a stapling apparatus 400 adapted for providing said reversible connection by said active reversible connection mechanism. Said stapling apparatus 400 comprises a frame 401 which holds the distal portion 101 of an implant deployment device 100. Four staplers 403 are connected to the frame 401 at each cornet by four separate hinges (either standard or living hinges). Each said stapler 403 is adapted to push down the implant 210 through a pair of clip 107 and to transform said clips 107 from a vertical position into a horizontal position (thus providing said reversible connection). Stapling presses 404 are located at the end of each stapler inside groove 405 and adapted to push clip 107 into horizontal position. Each pair of staplers 403 is connected via bridge 407 in order to prevent lateral movement of said staplers 403 during the stapling process. A snap groove 406 is located at the center of the frame 401 and adapted to reversibly hold said implant deployment device 100 attached to stapling apparatus 400 until said reversible attachment is obtained.
Each pair of clip 107 is held in a vertical position by clip holder 402. Each said clip holder 402 is adapted to hold a pair of clip 107 in vertical position in order to allow its insertion through the implant 210 during the stapling process. In addition, clip holder 402 is adapted the hold the clips vertical during shipment in order to allow stapling in the operation room without the need of any preparation. As illustrated in FIGS. 4B-4C, each clip holder 402 comprises two grooves 408 which hold the clip 107 in a vertical position. Once stapling process is performed and the surgeon is lowering the stapler 403 toward the implant, each clip holder 402 is pushed down and as a result it is also moving laterally. In this state, since the clip 107 are extracted from groves 408, their transformation from vertical into horizontal position is enabled; said lateral movement of said clip holder 402 is obtained as bulge 409 at clip holder 402 is sliding along bulge 410 at the stapling frame 401 during the down movement of clip holder 402.
FIGS. 4D-4G illustrate the process of connecting the implant 210 to one pair of clip. At the initial stage (FIG. 4D), the clips are held vertically by clip holder 402. Next, an implant 210 is places on top of the stapling apparatus (FIG. 4E); the stapler 403 is then lowered toward the implant 210 by the surgeon (or other member of the medical staff); as a result the two clip 107 are penetrating through implant 210 and into groove 405 (FIG. 4F). During the initial penetration, clip 107 is held by clip holder 402, thus premature transformation from vertical into horizontal position is prevented. Once the clip 107 are completely inserted into said implant 210, clip holder 402 is positioned laterally relative to the clip 107 (as also described is FIGS. 4B-4C); at this stage the surgeon push on stapler press 404 and lower it toward clip 107 (FIG. 4G), as a result clip 107 position is transformed form vertical position into horizontal position. Since the said lock bar 203 is located at its said lock position, once clip 107 are substantially horizontal position, they are locked in this stage, thus providing said reversible connection between implant 210 and implant deployment device 100. Once said connection is obtain with all clip 107, implant deployment device is removed from SA 400.
FIG. 4H illustrates the configuration of stapling apparatus 400 during shipment. In order to reduce package volume during shipment and to keep the device ready for stapling, at least one, preferably two, packaging caps 411 are utilized. Said caps 411 are reversibly attached to the frame 401, and adapted to retain stapler 403 in a substantially horizontal position during device shipment. In addition, said caps 411 also prevent down movement of stapler press 404, prevent lateral movement of clip holder 402 and prevent non-deliberate extraction of implant deployment device 100 from frame 401.
Once the device in removed from its packaging during the surgery, said pack caps 411 are removed by the medical staff in order to allow stapling of the implant 210 to the implant deployment device 100. Once the caps 411 are removed, the staplers 403 springs into horizontal position allowing the placement of implant 210 onto the stapling apparatus 400 and implant deployment device 100.
In order to allow tight spreading of the implant 210 during surgery, said stapling process is preformed while implant deployment device 100 is not completely opened; as a result, once implant deployment device is completely opened inside the abdominal cavity, it is stretched beyond its original dimension (as was during stapling) therefore tight spreading is obtained.
Reference is now being made to FIG. 5 which illustrates an embodiment of a staple return spring 500. In general, staple return spring 500 is needed in order to return clip 107 into horizontal position immediate after detachment from the implant 210; this is necessary in order prevent damage to internal organs by the sharp tip of clip 107 and in order to prevent clip 107 from being caught at the trocar or at the tissue during device extraction.
Referring to FIG. 6, an embodiment of a clip 601 for use with an implant deployment device 100 is illustrated. Clip 601 includes a hook 603, similar to the protruding portion 201 of FIG. 2 as described above, a body portion 605, an extending portion 607, and a hinge hole 611 similar to the hinge holes 133 of FIG. 2 as described above. Clip 601 also includes a notch 613 formed in extending portion 607 and a prong 617 created in the extending portion 607 formed by the addition of the notch 613 to the extending portion 607. The notch 613 may be shaped as desired to releasably engage a head of a spring member as described herein. Clip 601 also includes a flattened bottom surface 615.
Referring specifically to FIG. 7, a lock bar 700 includes a lock bar body portion 704 and at least one spring member 702 attached to the lock bar body portion 704, and configured to provide a restoring force to move a clip 601 from an open position to a closed position. As herein described with respect to this and future embodiments, an open position is any position where the hooks 603 as herein described are not in contact with or in close proximity to the frame arm 104, a closed position is where the hooks 603 are in contact with or in close proximity to the frame arm to clamp a desired implant, and an intermediate position is between the open position and the closed position.
As shown in FIG. 7, the spring member 702 includes a base portion 705 attached to the lock bar body portion 704, a flex member 703, and a head 701 extending from the flex member 703. Spring member 702 may be integrally formed at the base portion 705 from the lock bar body portion 704 or may be a separate piece permanently or removably attached to the lock bar body portion 704. The spring member 702 and the components thereof may be made from one continuous material, or formed from separate materials. In some embodiments, the spring member 702 is made of nitinol.
The flex member 703 is shown as an elongated section of material, similar to a leaf spring, which can flex and provide a restoring force opposite the direction of flexion. The flex member 703 may be made from any suitable semi rigid material that that can flex and provide a restoring force sufficient to rotate the clips 601 into a closed position. The thickness and length of the flex member 703 may be modified to achieve a desired effective spring constant/spring force as a function of flexion.
Optionally, the lock bar 700 may further include additional springs 709 attached thereto for modifying the overall spring constant or stability of the spring members 702.
The head 701 extending from the flex member 703 may be a cammed protrusion shaped to releasably engage the notch 613 of clip 601, and further engage the flat bottom surface 615 of clip 601. The head 701 may be shaped such that a desired force may disengage the head 701 from the notch 613. Also, the head 701 may have a flat surface to slidably and/or flushly engage the flat surface 615 of clip 601 when the head 701 is not engaging notch 613.
As shown in FIG. 8A, the head 701 of each spring member 702 engages the notch 613 of each clip 601 such that the clips 601 are locked in an open position. However, as described above, the head 701 is shaped such that the clips 601 may rotate with enough applied force to disengage the head 701 as shown in FIG. 8B. Also shown in FIG. 8B is the flexion of flex member 703 when the clip 601 is in an intermediate position between the open and closed positions. The flexion of flex member 703 provides a restoring force against the flat bottom surface 615 of clip 601 such that the head 701 pushes against the prong 617 or bottom surface 615 to create a torque about the hinge hole 611. As shown in 8C, the spring member 702 forces the clip 601 into a closed position. The head 701 may thereafter flushly engage the flat bottom surface 615 to limit any further rotation until the user slides the lock bar 700 such that the head 701 no longer engages the flat bottom surface 615 of clip 601.
Referring to FIG. 9, a lock bar 900 includes a spring member 902 including a base portion 905 attached to the lock bar body portion 904, at least two flex members 903 opposite each other, and a head 901 extending from each flex member 903. Similar to the embodiment above, spring member 902 may be integrally formed at the base portion 905 from the lock bar body portion 904 or may be a separate piece permanently or removably attached to the lock bar body portion 904. The spring member 902 and the components thereof may be made from one continuous material, or formed from separate materials. In some embodiments, the spring member 902 is made of nitinol.
As shown in FIG. 9, the spring member 902 may be configured for clip 601 pairs such that multiple flex members 903 emanate from a single base portion 905. FIGS. 10A-10C show the lock bar 900 in an open position (10A), an intermediate position (10B), and a closed position (10C). As shown in FIG. 10A, the head 901 of each spring member 902 engages the notch 613 of each clip 601 such that the clips 601 are locked in the open position. However, as described above, the head 903 is shaped such that the clips 601 may rotate with enough applied force to disengage the head 901 from the notch 613 as shown in FIG. 10B. Also shown in FIG. 10B is the flexion of flex member 903 when the clip 601 is in the intermediate position between the open and closed positions. The flexion of flex member 903 provides a restoring force against the flat bottom surface 615 of clip 601 such that the head 901 pushes against the prong 617 or bottom surface 615 to create a torque about the hinge hole 611. As shown in 10C, the spring member 902 urges the clips 601 into a closed position. The head 901 may thereafter flushly engage the flat bottom surface 615 to limit any further rotation until the user slides the lock bar 900 such that the head 901 no longer engages the flat bottom surface 615 of clip 601.
However, in some embodiments, the flexibility of the flex member 703, 903 may allow the clip 601 to continue to rotate, in which additional stops may be necessary to adequately lock the clips 601 in the closed position. For example, referring to FIG. 11, a lock bar 1100 includes a spring member 1102 including a base portion 1105 attached to the lock bar body portion 1104, at least one flex member 1103, and a head 1101 extending from flex member 1103. Similar to the embodiments above, spring member 1102 may be integrally formed at the base portion 1105 from the lock bar body portion 1104 or may be a separate piece permanently or removably attached to the lock bar body portion 1104. The spring member 1102 and the components thereof may be made from one continuous material, or formed from separate materials. In some embodiments, the spring member 1102 is made of nitinol.
Lock bar 1100 further includes stop members 1111, 1107 for locking clips 601 into the closed position. For example, referring to FIGS. 12A and 12B, the lock bar 1100 is slid back from a first unlocked position, as shown in FIG. 12A, to a locked position, as shown in FIG. 12B, wherein the stop members 1111, 1107 are in contact with the bottom surface 615 of clips 601 such the stop members 1111, 1107 limit any movement of clips 601 while in the locked position.
Utilizing one or more embodiments of the clip and lock bar systems as herein disclosed biases the clips 601 such that the hook portions 603 of the clips 601 tend to push against the frame arm 104 and hold down any mesh thereto attached. The clips 601 may be initially locked in an open position allowing a clinician to push the hooks 603 through a surgical implant such as a surgical mesh. After the implant has been engaged with the hooks 603, the clinician may release the lock allowing the spring members as herein described to force each clip 601 into a closed position, thereby compressing the surgical implant against the one or more frame arms 104. When deployment is desired, the clinician may force the clips 601 into the open position against the bias generated by the spring members, thereby allowing the surgical implant to be removed from the hooks 603. After the implant is removed and placed at a desired surgical site, the clinician may then allow the restoring force due to flexion of the flex members to return the clips 601 to the closed position to facilitate the clinician removing the deployment device from the patient.
INCORPORATION BY REFERENCE
References and citations to other documents, such as patents, patent applications, patent publications, journals, books, papers, web contents, have been made throughout this disclosure. All such documents are hereby incorporated herein by reference in their entirety for all purposes.
EQUIVALENTS
The invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The foregoing embodiments are therefore to be considered in all respects illustrative rather than limiting on the invention described herein. Scope of the invention is thus indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.

## Claims

1. A system for closing an aperture in biological tissue, the system comprising:
a proximal portion adapted to remain outside a body;
a distal portion adapted to be inserted into the body, the distal portion including at least one frame arm;
at least one clip connected to the at least one frame arm and configured to releasably retain a surgical implant to the at least one frame arm;
a lock bar including a body portion and at least one spring member disposed thereon configured to bias the at least one clip towards a closed position when the at least one clip is in an intermediate position between an open position and the closed position, the at least one spring member further comprises a base portion disposed on or formed from the lock bar, a flex member attached to the base portion and configured to elastically flex and provide a restoring force, and a head disposed on the flex member configured to engage the at least one clip and apply the restoring force to the at least one clip, the at least one clip further including a bottom surface wherein the head contacts the bottom surface of the at least one clip in at least one position; and
an extending portion forming a notch, wherein the extending portion includes at least one prong, wherein the head releasably engages the notch to hold the at least one clip in the open position.

2. The system of claim 1, wherein the at least one clip further comprises an extending portion forming a notch, wherein the extending portion includes at least one prong.

3. The system of claim 1, wherein the bottom surface is substantially flat.

4. The system of claim 1, wherein the head is cammed to allow the head to slide out of engagement with the notch over the at least one prong as the at least one clip is torqued with a desired force to release the at least one clip from the open position.

5. The system of claim 4, wherein the head contacts the bottom surface of the at least one clip when the head is out of engagement with the notch.

6. The system of claim 5, wherein the at least one clip further includes a hook, wherein when the at least one clip is in the open position such that the hook is not in contact with the at least one frame arm, the bottom surface of the at least one clip forces the head downward and bends the flex member so that the flex member provides the restoring force through the head to the at least one clip to bias the at least one clip toward the closed position.

7. The system of claim 6, wherein the lock bar further includes at least one stop member that slidably contacts the bottom surface of the at least one clip when the lock bar is moved from an unlocked position to a locked position.

8. The system of claim 1, further including at least two clips, wherein the at least one spring member of the lock bar simultaneously biases the at least two clips towards the closed position when the at least two clips are in an intermediate position between the open position and the closed position.

9. The system of claim 8, wherein the lock bar is operably coupled to the at least two clips such that the at least two clips transition between the open position and the closed position in unison.

10. The system of claim 1, wherein the lock bar cooperatively engages a first clip and a second clip, such that rotation of the first clip between the open position and the closed position loads the at least one spring member, the at least one spring member acting to simultaneously rotate the second clip between the open position and the closed position.

11. A system for closing an aperture in biological tissue, the system comprising:
a proximal portion adapted to remain outside a body;
a distal portion adapted to be inserted into the body, the distal portion including at least one frame arm;
at least one clip connected to the at least one frame arm and configured to releasably retain a surgical implant to the at least one frame arm, wherein the at least one clip includes a hook, a body portion, a hinge hole, wherein the at least one clip further includes a flat bottom surface, an extending portion forming a notch, wherein the extending portion includes at least one prong; and
a lock bar including a body portion and at least one spring member disposed thereon configured to bias the at least one clip towards a closed position, wherein the at least one spring member further comprises a base portion disposed on or formed from the lock bar, a flex member attached to the base portion and configured to elastically flex and provide a restoring force, and a head disposed on the flex member configured to engage the at least one clip and apply the restoring force to the at least one clip, wherein the head contacts the bottom surface of the at least one clip in at least one position, wherein the head releasably contacts the notch to hold the at least one clip in an open position, wherein the head and notch are cammed to allow the head to slide out of engagement with the notch over the at least one prong as the at least one clip is torqued with a desired force to release the at least one clip from the open position, wherein the head engages the bottom surface of the at least one clip when the head is out of engagement with the notch, wherein when the at least one clip is in an intermediate position such that the hook is not in contact with the frame arm, the bottom surface of the at least one clip forces the head downward and bends the flex member so that the flex member provides the restoring force through the head to the at least one clip to bias the at least one clip toward the closed position when the at least one clip is in the intermediate position between the open position and the closed position.